CompletedPhase 3

Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

China240 participantsStarted 2010-03

Plain-language summary

To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. PCA.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients of either sex aged 18 to 65 years old, with a standard body weight \[standard body weight = height (cm) - 100\] ±15%.
✓. ASA I and II.
✓. Scheduled on elective open upper abdominal surgery under general anesthesia (liver, gall bladder, spleen, stomach, kidney, colon surgery), of which predicted operation duration is between 2-4h.
✓. Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.
✓. Patients who are willing to participate in the study and have signed the written informed consent.
✓. Negative pregnancy test result should be obtained for women of child-bearing age.

Exclusion criteria

✕. Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.
✕. Body weight is less than or over ±15% of the standard body weight.
✕. Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).
✕. Medical history of recovering from abnormal surgery anesthesia.
✕. Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).
✕. Esophagus reflux disease.
✕. Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.
✕. Have known hypersensitivity to opioids.

What they're measuring

Measuring VAS

Timeframe: 3h post-operation

Measuring VAS

Timeframe: 24 hours post operation

Measuring VAS

Timeframe: 48 hours post operation

Trial details

NCT IDNCT01304134

SponsorMundipharma (China) Pharmaceutical Co. Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-08

View on ClinicalTrials.gov More Other Acute Postoperative Pain trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients of either sex aged 18 to 65 years old, with a standard body weight \[standard body weight = height (cm) - 100\] ±15%.
✓. ASA I and II.
✓. Scheduled on elective open upper abdominal surgery under general anesthesia (liver, gall bladder, spleen, stomach, kidney, colon surgery), of which predicted operation duration is between 2-4h.
✓. Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments.
✓. Patients who are willing to participate in the study and have signed the written informed consent.
✓. Negative pregnancy test result should be obtained for women of child-bearing age.

Exclusion criteria

✕. Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol.
✕. Body weight is less than or over ±15% of the standard body weight.
✕. Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr).
✕. Medical history of recovering from abnormal surgery anesthesia.
✕. Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg).
✕. Esophagus reflux disease.
✕. Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation.
✕. Have known hypersensitivity to opioids.